Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06403319
Other study ID # OME-S-24-00723
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2009
Est. completion date December 31, 2020

Study information

Verified date May 2024
Source Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Otitis media with effusion (OME) is thought to be associated with comorbidities such as allergic rhinitis, gastroesophageal reflux disease, asthma, and more. Many of these comorbidities can be caused by type 2 inflammation (T2I). This study aims to characterize the risk of undergoing OME surgery. This retrospective, matched-cohort study involved the retrospective recruitment of patients from 2009 to 2020, using the Taiwan National Health Insurance Research Database (NHIRD)


Recruitment information / eligibility

Status Completed
Enrollment 100622
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosis of OME - At least two outpatient visits or one hospitalization record - Medical records within the database Exclusion Criteria: - Participants younger than 4 years old - Participants with unclear demographic information - Participants with a history of ear surgery or congenital ear anomalies - Participants who had undergone OME surgery before the index date

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Primary The number of participants with OME who requiring surgical intervention surgical intervention including procedures such as myringotomy and adenoidectomy 10 years
See also
  Status Clinical Trial Phase
Completed NCT03590912 - Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion Phase 4
Completed NCT03611842 - Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
Not yet recruiting NCT01421199 - Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children N/A
Completed NCT01202578 - Evaluation of the Tympanostomy Tube Delivery System Phase 2/Phase 3
Completed NCT00629694 - Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy Phase 2
Completed NCT00520039 - Osteopathic Otitis Media Research Study N/A
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Not yet recruiting NCT05402267 - The Effects of Exosomes in Otitis Media With Effusion
Not yet recruiting NCT04584073 - Secretory Otitis Media in Adenoids Hypertrophy Patients N/A
Withdrawn NCT00736112 - Food Allergy - Tubes - Adenoids (FATA) Trial N/A
Completed NCT00546117 - A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion N/A
Withdrawn NCT02950311 - Xylitol for Otitis Media Phase 2/Phase 3
Recruiting NCT05324696 - Autoinflation: Alternative in the Treatment of Otitis Media With Effusion N/A
Recruiting NCT05353569 - Coherent Optical Detection of Middle Ear Disease N/A
Completed NCT02282540 - Novel Imaging of the Eustachian Tube; Patient Study N/A
Not yet recruiting NCT03491098 - The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study Early Phase 1
Completed NCT01082029 - Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children Phase 4
Completed NCT00939796 - Clinical Study of the Tympanostomy Tube Delivery System N/A
Recruiting NCT06316635 - Microplastics in Otitis Media With Effusion Material
Recruiting NCT02215681 - Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study N/A